Is this your brand? Sign in to claim ownership.
Sign in to claim this brandAesku.Diagnostics GmbH & Co. KG
US
Last updated May 24, 2026
What Aesku.Diagnostics GmbH & Co. KG makes
Aesku.Diagnostics GmbH & Co. KG manufactures in vitro diagnostic (IVD) kits for autoimmune and connective tissue disease testing, including enzyme immunoassays (EIA) for coeliac disease-associated antibodies, anticardiolipin antibodies, antinuclear antibodies (ANA), and anti-neutrophil cytoplasmic antibodies (ANCA), as well as fluorescent immunoassays for ANA screening and ANCA detection. Specific products target tissue transglutaminase antibodies, anti-dsDNA antibodies, and B2-glycoprotein I complexes. The portfolio also includes fluorescent slides for ANA screening using Crithidia luciliae.
The company’s diagnostic kits are classified under FDA categories, with most falling into Class I and Class II regulatory classifications. These devices are listed via the FDA’s 510(k) pathway and the Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 341714388
Catalogue (97)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AESKULISA® Glia-A | 3501 | FDA UDI | Class II | Active |
| AESKUSLIDES nDNA (Crithidia luciliae) | 53.100.US | FDA UDI | Class II | Active |
| AESKULISA® snRNP-C | 3105 | FDA UDI | Class II | Unknown |
| AESKULISA® Glia-A | 30-7501US | FDA UDI | Class II | Active |
| Aeskulisa® Ena-6s | 7102US | FDA UDI | Class II | Active |
| AESKULISA® Cardiolipin-Check | 3202 | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-Check | 30-7215US | FDA UDI | Class II | Active |
| AESKULISA® Glia-G | 30-7502US | FDA UDI | Class II | Active |
| AESKULISA® PR3 sensitive | 30-7302US | FDA UDI | Class II | Active |
| Aeskulisa® Dgp-A | 3513 | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-GM | 30-7206US | FDA UDI | Class II | Active |
| Aeskulisa® Ss-B | 3110 | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-A | 7205US | FDA UDI | Class II | Active |
| Aeskulisa® Ss-B | 7110US | FDA UDI | Class II | Active |
| Aeskulisa® Mpo | 30-7303US | FDA UDI | Class II | Active |
| AESKULISA® Scl-70 | 3111 | FDA UDI | Class II | Active |
| AESKULISA® Cenp-B | 7112US | FDA UDI | Class II | Active |
| AESKUSLIDES ANCA Formalin | 54.101.US | FDA UDI | Class II | Active |
| Aeskulisa® Ena-6s | 3102 | FDA UDI | Class II | Active |
| AESKULISA® Glia-A | 7501US | FDA UDI | Class II | Active |
| AESKULISA® ENA-6Pro | 7103US | FDA UDI | Class II | Active |
| AESKUSLIDES ANCA Ethanol | 54.050.US | FDA UDI | Class II | Active |
| AESKULISA® Jo-1 | 7113US | FDA UDI | Class II | Active |
| Aeskulisa® Asca-A | 7507US | FDA UDI | Class II | Active |
| AESKULISA® Scl-70 | 7111US | FDA UDI | Class II | Active |
| AESKULISA® DGP-Check | 30-7515US | FDA UDI | Class II | Active |
| Aeskulisa® Asca-G | 30-7508US | FDA UDI | Class II | Active |
| AESKUSLIDES® ANA-HEp-2 | 51.100 | FDA UDI | Class II | Unknown |
| Aeskulisa® U1-70 | 7104US | FDA UDI | Class II | Active |
| AESKULISA® Cenp-B | 3112 | FDA UDI | Class II | Active |
| AESKULISA® DGP-Check | 3515 | FDA UDI | Class II | Active |
| AESKULISA® Cardiolipin-GM | 3204 | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-A | 3205 | FDA UDI | Class II | Active |
| Aeskulisa® Asca-A | 30-7507US | FDA UDI | Class II | Active |
| AESKULISA® Jo-1 | 3113 | FDA UDI | Class II | Active |
| AESKULISA tTg-G New Generation | 7504US | FDA UDI | Class II | Active |
| AESKUSLIDES® nDNA (Crithidia luciliae) | 53.120.US | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-Check | 3215 | FDA UDI | Class II | Active |
| AESKUSLIDES® ANA-HEp-2 | 51.100.US | FDA UDI | Class II | Active |
| AESKULISA® dsDNA-G | 7142US | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-GM | 3206 | FDA UDI | Class II | Active |
| AESKULISA tTg-A New Generation | 30-7503US | FDA UDI | Class II | Active |
| AESKULISA tTg-G New Generation | 30-7504US | FDA UDI | Class II | Active |
| AESKULISA® PR3 sensitive | 3302 | FDA UDI | Class II | Active |
| HELIOS® Automated IFA System | REF.IOS-1000.US | FDA UDI | Class II | Active |
| AESKULISA® ANA-HEp-2 | 3115 | FDA UDI | Class II | Active |
| Aeskulisa® Dgp-G | 30-7514US | FDA UDI | Class II | Active |
| Aeskulisa® Asca-G | 7508US | FDA UDI | Class II | Active |
| AESKULISA® ß2-Glyco-A | 30-7205US | FDA UDI | Class II | Active |
| Aeskulisa® Dgp-A | 30-7513US | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- AESKU.DIAGNOSTICS GmbH&Co.KG WENDELSHEIM Rhineland-Palatinate · DE FEI 3003825930